US-based Inhalon Biopharma is set to launch a trial of its at-home nebulised treatment for respiratory syncytial virus (RSV) as part of FluCamp.
Inhalon’s candidate IN-002 will be investigated in a human challenge study in collaboration with the German contract research organisation (CRO) hVIVO. The CRO confirmed that it will take advantage of FluCamp to recruit patients for the 2026 trial.
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FluCamp enrols healthy people to participate in clinical trials to investigate therapies for diseases such as RSV.
The company is launching the Phase II trial after completing investigative new drug (IND)-enabling studies and seeing success in trials using animal models.
A human challenge trial typically involves intentionally exposing a patient to an infection to test a treatment.
Inhalon Biopharma’s president and chief executive officer John Whelan said: “Preventive immunisations are underutilised, especially in RSV, where vaccine usage is now expected to be one-third of original estimates.
“As many as 30%-50% of immunised patients experience breakthrough infection, leaving vulnerable populations – infants, toddlers, and the elderly – at high risk of severe infection. There are currently no approved treatments for the underlying RSV infection.
“Inhalon’s inhaled antibody treatment approach not only targets the underlying pathophysiology of RSV and other respiratory infections but also provides painless, self-administration by patients in their own homes, potentially reducing hospitalisations.”
Inhalon hopes its direct inhaled delivery of IN-002 into the lung will be more effective in combating RSV infections.
IN-002 is not the only therapy in Inhalon’s pipeline. The company is investigating another inhaled antibody therapy candidate, IN-006 in Covid-19. In a Phase I trial of IN-006 carried out in Australia (ACTRN12621001235897) comparing an Inhalon-developed inhaled antibody therapy against intravenous treatment for the treatment of Covid-19, the company saw inhaled antibodies achieving concentrations exceeding the levels required to treat many respiratory viruses.
Market research by GlobalData estimates that by 2030 the market for RSV prophylactic products is set to $16bn, up from a value of $582m by the end of 2020.
GlobalData is the parent company of Clinical Trials Arena.
Elsewhere in the RSV treatment market, Japanese company Shionogi’s oral antiviral for RSV has met its primary endpoint in a Phase II study that saw some participants achieving an 88.94% reduction in viral load. Meanwhile, Blue Lake Biotechnology’s paediatric nasal vaccine for RSV, BLB201, was found to be safe and effective for paediatric patients in a Phase I/IIa trial.
